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Comparison of Mechanical Penetration Enhancers on Metvixia Skin Penetration

NCT ID: NCT02511145

Last Updated: 2015-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-05-31

Brief Summary

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Exploratory, mono-center, randomized, intra-individual, controlled trial involving healthy volunteers to compare the effect on MAL penetration into the skin following various mechanical penetration enhancement techniques.

Detailed Description

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At baseline, each mini-zone was selected and randomly assigned to a pretreatment: 3 zones with microneedling Dermaroller®, 3 zones with ablative fractional CO2 Laser, and 3 zones with no pretreatment. After performing pretreatment, MAL cream was applied on the 6 assigned mini-zones for 3 hours incubation. Each condition was tested with and without occlusion. The three mini-zones with no product applied were used to perform biophysics measures.

Conditions

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Healthy

Keywords

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volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Microneedles pretreatment and Metvixia

minizone with Microneedles pretreatment and Metvixia cream application

Group Type ACTIVE_COMPARATOR

Microneedles pretreatment

Intervention Type DEVICE

METVIXIA Cream

Intervention Type DRUG

Microneedles pretreatment and Metvixia under occlusion

minizone with Microneedles pretreatment and Metvixia cream application with occlusion

Group Type ACTIVE_COMPARATOR

occlusive bandage

Intervention Type OTHER

Microneedles pretreatment

Intervention Type DEVICE

METVIXIA Cream

Intervention Type DRUG

Laser pretreatment and Metvixia

minizone with laser pretreatment and Metvixia cream application

Group Type ACTIVE_COMPARATOR

ablative fractional CO2 laser pretreatment

Intervention Type DEVICE

METVIXIA Cream

Intervention Type DRUG

Laser pretreatment and Metvixia under occlusion

minizone with Laser pretreatment and Metvixia cream application with occlusion

Group Type ACTIVE_COMPARATOR

occlusive bandage

Intervention Type OTHER

ablative fractional CO2 laser pretreatment

Intervention Type DEVICE

METVIXIA Cream

Intervention Type DRUG

Metvixia

minizone with Metvixia cream application, without pretreatment

Group Type ACTIVE_COMPARATOR

METVIXIA Cream

Intervention Type DRUG

Metvixia under occlusion

minizone with Metvixia cream application under occlusion, without pretreatment

Group Type ACTIVE_COMPARATOR

occlusive bandage

Intervention Type OTHER

METVIXIA Cream

Intervention Type DRUG

Microneedles pretreatment only

minizone with Microneedles pretreatment only

Group Type EXPERIMENTAL

Microneedles pretreatment

Intervention Type DEVICE

Laser pretreatment only

minizone with Laser pretreatment only

Group Type EXPERIMENTAL

ablative fractional CO2 laser pretreatment

Intervention Type DEVICE

Normal skin

Normal skin control mini-zone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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occlusive bandage

Intervention Type OTHER

ablative fractional CO2 laser pretreatment

Intervention Type DEVICE

Microneedles pretreatment

Intervention Type DEVICE

METVIXIA Cream

Intervention Type DRUG

Other Intervention Names

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Dermaroller MAL

Eligibility Criteria

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Inclusion Criteria

* Male or female of non childbearing potential, who is at least 18 years of age or older at screening visit.
* The subject has a skin phototype of I to III on Fitzpatrick's scale (Fitzpatrick et al., 1993) at screening visit.
* Subject should have 9 mini zone areas on the back that will be able to receive pre-treatments according to protocol. (checked at Screening visit, and assigned at Baseline visit)
* Female of non childbearing potential (postmenopausal \[absence of menstrual bleeding for 1 year prior to screening visit, without any other medical reason\], hysterectomy or bilateral oophorectomy).

Exclusion Criteria

* Subject with porphyria,
* Subject with past history of skin cancer, or current clinical diagnosis of other skin disease (including non-melanoma skin cancer), or tattoos, or cheloid and hypertrophic scars on the test zones, which, in the opinion of the investigator, might interfere with the interpretation of the clinical results,
* Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
* Known or suspected allergies or sensitivities to any components of any of the study drugs (see Product label).
* The subject has received, applied or taken some specific treatments within specified time frame prior to the baseline visit
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2013-003371-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RD.03.SPR.40221E

Identifier Type: -

Identifier Source: org_study_id